Regulatory Affairs Specialist

Regulatory Affairs Specialist
Strengthen a leading diagnostics company in Rotkreuz as a Regulatory Affairs Specialist and ensure that third-party medical devices and IVDs comply with all EU regulations.
Regulatory Affairs Specialist
Job description:
For our client, a leading international company in the diagnostics and healthcare sector, we are looking for an experienced Regulatory Affairs Contractor to strengthen the team in Rotkreuz.
The focus of the position is on the independent regulatory verification and assessment of third-party medical devices and in-vitro diagnostics (IVDs) in accordance with applicable European and Swiss regulatory requirements.
About the customer:
Start: ASAP
Duration: 6 months
Work location: Rotkreuz, Switzerland
Workload: 100%
Team: 7 people
Requirements:
Independent regulatory examination and assessment of third-party medical devices and in-vitro diagnostics in accordance with EU MDR, EU IVDR, MepV and IvDV.
Examination of technical documentation, Declarations of Conformity (DoC), CE certificates, product labeling, and other regulatory evidence.
Verification of correct labeling for the market, especially regarding CH-REP (Representative) as well as importer obligations according to MepV/IvDV.
Direct communication with suppliers and external partners to request, examine, and clarify missing regulatory evidence and quality agreements.
Examination and verification of supplier and third-party documentation as part of release and compliance processes.
Support for the Person Responsible for Regulatory Compliance (PRRC) by preparing recommendations for the release or rejection of third-party products for the market.
Operational support in the area of Regulatory Affairs as needed, for example, with supplier inquiries and the review of regulatory documentation.
Competences:
Successfully completed degree in medical technology, natural sciences, industrial engineering, or a comparable qualification.
At least 3 years of professional experience in Regulatory Affairs and/or Quality Management within the MedTech or IVD industry.
In-depth practical knowledge of EU MDR (2017/745) and EU IVDR (2017/746).
In-depth knowledge of the Medical Device Ordinance (MepV) and In-vitro Diagnostic Medical Devices Ordinance (IvDV).
Practical experience with 3rd-party processes, particularly in auditing, releasing, and/or verifying supplier and third-party documentation.
Experience in examining technical documentation, Declarations of Conformity, CE certificates, and product labeling is a great advantage.
Independent and structured way of working, as well as the ability to conduct regulatory assessments and recommendations independently.
Fluent German and English language skills, both written and spoken.